A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

August 12, 2020

Primary Completion Date

August 31, 2026

Study Completion Date

October 31, 2026

Conditions
Advanced Malignant NeoplasmBreast CancerOvarian CancerHomologous Recombination DeficiencyProstate CancerPancreatic Cancer
Interventions
DRUG

AMXI-5001:Dose Escalation Phase I

Phase I will enroll up to 70 participants to identify the Recommended Phase II daily dose in the treatment of various cancers and to characterize the safety, pharmacology, and clinical efficacy of AMXI-5001. AMXI-5001 is administered orally twice daily, with food. AMXI-5001 is administered weekly on a continuous 7-day schedule. Each cycle is 28 days.

DRUG

AMXI-5001:Dose Expansion Phase II

Phase II will enroll up to 52 study participants to further characterize the safety, pharmacology, and clinical efficacy of AMXI-5001. AMXI-5001 is administered orally twice daily, with food. AMXI-5001 is administered weekly on a continuous 7-day schedule. Each cycle is 28 days.

Trial Locations (4)

21218

RECRUITING

Johns Hopkins, Baltimore

37203

RECRUITING

SCRI Oncology Partners, Nashville

77030

RECRUITING

The University of Texas MD Anderson Cancer Center, Houston

90404

RECRUITING

University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology, Los Angeles

All Listed Sponsors
lead

AtlasMedx, Incorporated

INDUSTRY